A Comparative Study to Evaluate the Effectiveness between Synergic Activities of 0.1% Polyhexanide and Rigenase® (Fitostimoline® Plus spray) versus a Hydrating Formulation for the Topical Management of Rubbing Injuries Secondary to Atopic Dermatitis

Introduction: Managing rubbing injuries in atopic dermatitis is challenging and has a significant impact on patients' quality of life. Polyhexamethylene biguanide (PHMB) and Rigenase® (a patented Triticum vulgare extract) show promise in tissue repair and antimicrobial activity. Objective: T...

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Main Authors: Eugenia Veronica Di Brizzi, Anna Balato, Stefano Caccavale, Amalia Lupoli, Carlo Panetti, Giuseppe Argenziano
Format: Article
Language:English
Published: Mattioli1885 2025-01-01
Series:Dermatology Practical & Conceptual
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Online Access:https://dpcj.org/index.php/dpc/article/view/4906
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author Eugenia Veronica Di Brizzi
Anna Balato
Stefano Caccavale
Amalia Lupoli
Carlo Panetti
Giuseppe Argenziano
author_facet Eugenia Veronica Di Brizzi
Anna Balato
Stefano Caccavale
Amalia Lupoli
Carlo Panetti
Giuseppe Argenziano
author_sort Eugenia Veronica Di Brizzi
collection DOAJ
description Introduction: Managing rubbing injuries in atopic dermatitis is challenging and has a significant impact on patients' quality of life. Polyhexamethylene biguanide (PHMB) and Rigenase® (a patented Triticum vulgare extract) show promise in tissue repair and antimicrobial activity. Objective: The aim of this study was to compare the effectiveness of two topical treatments, Fitostimoline® Plus spray and a hydrating formulation with hyaluronic acid, in rubbing injuries secondary to atopic dermatitis. Materials and Methods: This comparative study enrolled 68 patients with atopic dermatitis and rubbing injuries, randomly assigned to Group A (N=38) receiving Fitostimoline® Plus spray (0.1% PHMB and Rigenase®) or Group B (N=30) receiving a hyaluronic acid spray. The primary endpoint was the clinical lesion response at 10 days post-treatment. Secondary endpoints included pain reduction (Visual Analogue Scale, VAS) and patient satisfaction (Dermatology Life Quality Index,DLQI). Results: Group A had a significantly higher complete response rate (81.3% vs. 64.3%, P <0.001). Partial response rates were also higher in Group A (P = 0.045). Pain reduction was greater in Group A (VAS: 6.8 ± 1.2 to 2.4 ± 0.8) compared to Group B (7.1 ± 1.3 to 3.9 ± 1.0) (P <0.001). DLQI scores improved more in Group A (12.5 ± 3.5 to 3.2 ± 1.1) than in Group B (13.0 ± 3.2 to 6.5 ± 1.4) (P <0.001). Dermoscopic examinations showed significant skin barrier improvement in Group A (P <0.001). Conclusion: Fitostimoline® Plus spray, with 0.1% PHMB and Rigenase®, offers superior treatment for chronic lesions in atopic dermatitis, enhancing wound healing and patient quality of life.
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spelling doaj-art-c604e12f628c4dcd80e22c72b92fda962025-02-04T15:41:28ZengMattioli1885Dermatology Practical & Conceptual2160-93812025-01-0115110.5826/dpc.1501a4906A Comparative Study to Evaluate the Effectiveness between Synergic Activities of 0.1% Polyhexanide and Rigenase® (Fitostimoline® Plus spray) versus a Hydrating Formulation for the Topical Management of Rubbing Injuries Secondary to Atopic DermatitisEugenia Veronica Di Brizzi0Anna Balato1Stefano Caccavale2Amalia Lupoli3Carlo Panetti4Giuseppe Argenziano5Dermatology Unit, University of Campania "L. Vanvitelli"Dermatology Unit, University of Campania, Naples, ItalyDermatology Unit, University of Campania, Naples, ItalyDermatology Unit, University of Campania, Naples, ItalyDermatology Unit, University of Campania, Naples, ItalyDermatology Unit, University of Campania, Naples, Italy Introduction: Managing rubbing injuries in atopic dermatitis is challenging and has a significant impact on patients' quality of life. Polyhexamethylene biguanide (PHMB) and Rigenase® (a patented Triticum vulgare extract) show promise in tissue repair and antimicrobial activity. Objective: The aim of this study was to compare the effectiveness of two topical treatments, Fitostimoline® Plus spray and a hydrating formulation with hyaluronic acid, in rubbing injuries secondary to atopic dermatitis. Materials and Methods: This comparative study enrolled 68 patients with atopic dermatitis and rubbing injuries, randomly assigned to Group A (N=38) receiving Fitostimoline® Plus spray (0.1% PHMB and Rigenase®) or Group B (N=30) receiving a hyaluronic acid spray. The primary endpoint was the clinical lesion response at 10 days post-treatment. Secondary endpoints included pain reduction (Visual Analogue Scale, VAS) and patient satisfaction (Dermatology Life Quality Index,DLQI). Results: Group A had a significantly higher complete response rate (81.3% vs. 64.3%, P <0.001). Partial response rates were also higher in Group A (P = 0.045). Pain reduction was greater in Group A (VAS: 6.8 ± 1.2 to 2.4 ± 0.8) compared to Group B (7.1 ± 1.3 to 3.9 ± 1.0) (P <0.001). DLQI scores improved more in Group A (12.5 ± 3.5 to 3.2 ± 1.1) than in Group B (13.0 ± 3.2 to 6.5 ± 1.4) (P <0.001). Dermoscopic examinations showed significant skin barrier improvement in Group A (P <0.001). Conclusion: Fitostimoline® Plus spray, with 0.1% PHMB and Rigenase®, offers superior treatment for chronic lesions in atopic dermatitis, enhancing wound healing and patient quality of life. https://dpcj.org/index.php/dpc/article/view/4906Atopic dermatitisRubbing injuriesFitostimoline® PlusRigenase® Wound healing
spellingShingle Eugenia Veronica Di Brizzi
Anna Balato
Stefano Caccavale
Amalia Lupoli
Carlo Panetti
Giuseppe Argenziano
A Comparative Study to Evaluate the Effectiveness between Synergic Activities of 0.1% Polyhexanide and Rigenase® (Fitostimoline® Plus spray) versus a Hydrating Formulation for the Topical Management of Rubbing Injuries Secondary to Atopic Dermatitis
Dermatology Practical & Conceptual
Atopic dermatitis
Rubbing injuries
Fitostimoline® Plus
Rigenase®
Wound healing
title A Comparative Study to Evaluate the Effectiveness between Synergic Activities of 0.1% Polyhexanide and Rigenase® (Fitostimoline® Plus spray) versus a Hydrating Formulation for the Topical Management of Rubbing Injuries Secondary to Atopic Dermatitis
title_full A Comparative Study to Evaluate the Effectiveness between Synergic Activities of 0.1% Polyhexanide and Rigenase® (Fitostimoline® Plus spray) versus a Hydrating Formulation for the Topical Management of Rubbing Injuries Secondary to Atopic Dermatitis
title_fullStr A Comparative Study to Evaluate the Effectiveness between Synergic Activities of 0.1% Polyhexanide and Rigenase® (Fitostimoline® Plus spray) versus a Hydrating Formulation for the Topical Management of Rubbing Injuries Secondary to Atopic Dermatitis
title_full_unstemmed A Comparative Study to Evaluate the Effectiveness between Synergic Activities of 0.1% Polyhexanide and Rigenase® (Fitostimoline® Plus spray) versus a Hydrating Formulation for the Topical Management of Rubbing Injuries Secondary to Atopic Dermatitis
title_short A Comparative Study to Evaluate the Effectiveness between Synergic Activities of 0.1% Polyhexanide and Rigenase® (Fitostimoline® Plus spray) versus a Hydrating Formulation for the Topical Management of Rubbing Injuries Secondary to Atopic Dermatitis
title_sort comparative study to evaluate the effectiveness between synergic activities of 0 1 polyhexanide and rigenase r fitostimoline r plus spray versus a hydrating formulation for the topical management of rubbing injuries secondary to atopic dermatitis
topic Atopic dermatitis
Rubbing injuries
Fitostimoline® Plus
Rigenase®
Wound healing
url https://dpcj.org/index.php/dpc/article/view/4906
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